I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
Connect with me on
Hot Science Jobs
GCP Inspector
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Dublin
Territory Manager (Clinical) - Leinster/
Dublin
Associate Scientist
Cork
Engineering Shift Technician
Dublin
Senior Quality Assurance Specialist
Dublin
Marketing Executive (Healthcare)
Dublin
R&D Extrusion Engineer
Galway
Product Planner
Longford
Director of Quality Engineering
Limerick
Automation Strategy Manager
Cavan
Senior R&D Engineer
Dublin
Clinical Trial Supply Management Associa
Cork
Snr Facilities Engineer
Dublin South
R&D Manager - Technologies for New P
Galway
Associate Director, Supply Chain
Dublin
Production Supervisor
Kildare
Project Engineer
Limerick
Senior Process Engineer
Cork
Lead Maintenance Reliability Engineer
Westmeath
Commissioning and Qualification Engineer
Dublin
Process Engineer
Republic of Ireland
Clinical Trials Project Manager
Cork
Quality Engineer
Limerick
Senior Clinical Research Associate
Dublin
Snr Supplier Quality Engineer
Galway
QC Bioassay Analyst
Cork
NPD Manager
Galway
Product Development Scientist
Galway
Program Manager
Galway
Process Validation Engineer
Cork
Supply Chain Project Support
Limerick
Senior Quality Engineer
Cork
Clinical Trial Supply Management Associa
Cork
Project Engineer
Limerick
Supply Chain Associate
Dublin
Senior Manufacturing Quality Engineer
Dublin
Capacity Consultant
Dublin
Senior Manufacturing Engineer
Cork
Clinical Trials Contracts and Budgets As
Cork
CQV/Validation Engineer
Dublin
QC Leader
Cork
R&D Manager
Galway
Engineering Technician
Dublin South
Technical Writer
Cork
Senior Quality Engineer
Galway
Technical Operations Specialist
Cork
Project Manager
Limerick
Senior Regulatory Affairs Specialist
Dublin
Senior Validation Engineer
Dublin
Director, Clinical Development (Oncology
South East
Business Process Senior Analyst
Cork
Engineering Technician
Dublin South
Design Assurance Engineer
Republic of Ireland
Quality Engineer II
Galway
Process Engineer
Limerick
Production Team Lead
Dublin South
Validation Engineer
Limerick
Regulatory Affairs Specialist
Republic of Ireland
Facilities Maintenance Technician
Dublin
Sales Manager (Healthcare)
Dublin
Senior Regulatory Affairs
Galway
Global Head of R&D
Republic of Ireland
Internal Product Manager (Cancer Genetic
Kilkenny
Head of R&D
Galway
Process Team Lead
Donegal
Regulatory Affairs Specialist
Cork
Equipment Project Engineer
Limerick
Senior Design Assurance Engineer
Galway
Quality Manager/ Lab Supervisor
Cork
Principal CAD Experience
Dublin
Marketing Manager (Healthcare)
Wexford
R&D Engineer
Galway
Qualified Person - Pharmaceutical
Cork
Senior QA Specialist
Dublin
Snr Supplier Quality Engineer
Galway
Clinical Trial Associate German Speaking
Cork
Demand & Inventory Manager
Galway
Vigilance Assessor
Dublin
Project Engineer
Limerick
Process Engineer
Galway
Quality - Tech Transfer Specialist
Cork
Senior Lab Services Associate
Dublin
Project Engineer
Limerick
Senior Polymer Development Engineer
Galway
Training Coordinator
Dublin
R&D Senior Program Manager
Galway
Business Development Manager (Chromatogr
Belfast City
Quality Specialist
Tipperary
Formulations Scientist
Offaly
Process Technician
Donegal
Commissioning and Qualification Lead - F
Dublin
Environmental Health & Safety Lead
Louth
R&D Engineer
Limerick City
Clinical Evaluator
Republic of Ireland
Quality Control Team Leader
Cork
QA Specialist
Cork
Clinical Scientific Expert
Dublin
R&D Manager
Galway
Clinical Sales Specialist (Diagnostics)
Dublin
Senior Product Development Engineer
Galway
Senior R&D Clinical Engineer
Republic of Ireland
Quality Systems Specialist
Limerick
Process Lead
Donegal
Snr EH&S Specialist
Longford
Project Engineer
Limerick
Senior Automation Engineer
Dublin South
Senior Design Assurance Engineer
Galway
Quality Assurance and Regulatory Affairs
Sligo
Automation Strategy Manager
Cavan
Senior Quality Engineer
Dublin
Controls Engineer
Dublin South
Manufacturing Specialist
Dublin South
Mechanical Engineer
Dublin
Manufacturing Quality Engineer
Galway
Scientific Officer
Kilkenny
Controls Engineer
Dublin South
Controls Engineer
Dublin South
Maintenance Technician- Nights
Galway
Electrical Design Engineer
Galway
Design Assurance Engineer
Galway
NPD Manager
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Validation Engineer
Limerick
Senior CSV Specialist- Hybrid
Republic of Ireland
Principal R&D Engineer
Dublin
Manufacturing Engineer
Galway
NPD Manager
Galway
EH&S Specialist
Longford
QA Contractor
Dublin City Centre
Senior Regulatory Affairs Specialist
Dublin
Publications Scientific Communications A
Cork
Maintenance Engineer
Cork
Research & Development Manager
Offaly
Maintenance Engineer/ Technician
Dublin South
Facilities Maintenance Technician
Dublin South
Senior Regulatory Affairs Specialist
Westmeath
Process Technician
Donegal
Quality Engineer
Limerick
Senior Associate External Planning and D
Dublin
C&Q Engineer
Dublin
Senior Manufacturing Engineer
Galway
Quality Engineer - Validation
Limerick
Senior R&D Engineer
Limerick City
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Process Engineer


Reference:RH/03052022 Location: Republic of Ireland
Waterford
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Process Engineer

Life Science Recruitment are recruiting two Process Engineers to join the team with our Biopharmaceutical client based in Waterford.


The purpose of this position is to be the subject matter expert in our Sterile Fill Finish maintenance operation and be a recognised expert in this industry. S/he needs to also ensure equipment is maintained in a validated state meeting cGMP requirements. Development, deployment and improvement of validation processes is key to ensure the maximum levels of performance and compliance are maintained.




Role & Responsibilities:


Engineering

  • Will be equipment SME for sterile operations with an indepth understanding of equipment functionality and process requirements.
Equipment Functionality
  • Understanding equipment operation in detail.
  • Defining and reviewing equipment specification and associated test documentation.
  • Support project delivery through FAT, SAT and IOQ involvement as needed.
  • Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing).
  • Strong focus on disciplined root cause analysis.
Process
  • Liaising with vendors on pre-sterilized components. Defining specifications and test requirements.
  • Liaising with vendors on disposable technology and integration into the process. Defining specification and test requirements.
  • Development of process cleaning and sterilization cycles.
  • Development of procedures and controls for High Containment applications.
  • Development of Leachable and extractable reports and studies as applicable.
  • Development of critical process parameters for the process and development of process capability and deviation monitoring.
  • Monitoring process risk and ensuring mitigations are in place as required. Implementation of data monitoring systems to ensure process control.
Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Quality Compliance
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Qualifications & Requirements:




Qualitfications & Experience
  • Qualified to a minimum of higher degree level in engineering or related discipline
  • Minimum 5 year’s engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
Skills
  • cGMP compliance.
  • Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem solving techniques.
  • Ability to understand engineering processes through a logical, data driven, hands on approach.
  • Knowledge of sterile and isolator technologies (including disposable technologies). Have an expertise in Fill Finish critical process parameters and product quality attributes.
  • Experience in Cycle development and validation for sterile manufacturing.
  • Use of FMEA, FMECA and Risk assessment techniques.
  • Familiar with statistical process control methods.
  • Operate SCADA systems and retrieve / interpret data.
  • Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
  • Proven track record of building relations with equipment vendors.
  • Strong report writing skills.

For more information contact Ruth Holland on 087 7822198 or [email protected]